Associate Director - Clinical Quality Assurance

Description:
? We are seeking a dynamic and results-driven Associate Director of Clinical Quality Assurance (CQA)
? This key role will report to the Head of Clinical Quality Assurance
? Responsible for assisting with the establishment of a robust QA system for our clinical operations
? Ensure compliance with regulatory standards, and promote a culture of quality throughout the organization

Requirements: ? Bachelor's degree in a relevant biological sciences or equivalent is required, advanced degree a plus ? 8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function ? Minimum of 6 years of direct audit experience in GCP ? In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements ? Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators ? Strong communication (oral and written), effective interpersonal skills with the ability to listen and drive change ? Excellent problem-solving and critical thinking abilities ? Flexible and creative to meet the needs and challenges of a growing, dynamic company ? Focus on fostering a culture of collaboration and teamwork ? Ability to manage multiple projects with aggressive timelines and changing priorities ? Ability and willingness to travel up to 25% per year including for company meetings

Benefits:
? A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
? Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
? Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
? Flexible PTO
? Two, one-week company-wide shutdowns each year
? Commitment to growing you professionally and providing access to resources to further your development
? Apogee offers regular all team, in-person meetings to build relationships and problem solve

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